No. 1
The Interim Measures for the Administration of Medicines for Basic Medical Insurance have been considered and adopted by the Board of Directors of the State Medical Security Bureau, and are hereby promulgated to come into force as of September 1, 2020.
Director: Hu Jinglin
July 30, 2020
Interim Measures for the Administration of Medicines for Basic Medical Insurance
Chapter 1 General Provisions
Article 1 In order to promote the construction of a healthy China, safeguard the basic needs of medicines for the insured, enhance the scientific and refined management of medicines for basic medical insurance, improve the use of the basic medical insurance fund, promote the governance system and governance capacity, and improve the efficiency and effectiveness of basic medical insurance. efficiency, and promote the modernization of the governance system and governance capacity, based on the Social Insurance Law of the People's Republic of China and other laws and regulations and the Opinions of the Central Government and the State Council on Deepening the Reform of the Medical Security System, the provisional measures are formulated.
The second medical security departments at all levels shall apply these measures to the determination and adjustment of the scope of medicines used in basic medical insurance, as well as the payment, management and supervision of medicines used in basic medical insurance.
Article 3 The scope of medicines for basic medical insurance is managed through the formulation of the Basic Medical Insurance Drug Catalog, and the costs of medicines in line with the Drug Catalog are paid for by the basic medical insurance fund in accordance with national regulations. The Drug Catalog implements generic name management, and drugs with the same generic name of the drugs in the Drug Catalog automatically fall within the scope of payment by the basic medical insurance fund.
Article 4 of the basic medical insurance medication management adhere to the people-centered development idea, and effectively protect the reasonable needs of the participants of the medication; adhere to the "basic" functional positioning, both to do their best, but also within the limits of their capabilities, the level of medication protection and the basic medical insurance fund and the participants of the affordability of the level; adhere to the hierarchical management, clearly defined at all levels of the medicines. The level of management, clear responsibilities and authority at all levels; adhere to expert evaluation, adapt to the progress of clinical technology, to achieve scientific, standardized, fine, dynamic management; adhere to the equal importance of Chinese and Western medicines, to give full play to the respective advantages of traditional Chinese medicine and Western medicine.
Article 5 of the "Drug Catalog" consists of five parts: vanilla, western medicines, proprietary Chinese medicines, negotiated medicines during the agreement period, and traditional Chinese medicine tablets. Provincial medical security administrative departments in accordance with national regulations to add a separate list of drugs. In order to maintain the safety of clinical use of medicines and improve the efficiency of the use of the basic medical insurance fund, the Drug Catalog restricts the conditions of medical insurance payment for some medicines.
Article VI of the State Council administrative department of medical insurance is responsible for the establishment of the basic medical insurance medication management system, the development and adjustment of the scope of the basic medical insurance medication, the use and payment of the principles, conditions, standards and procedures, etc., and the organization of the development, adjustment and release of the national "Drug Catalogue" and the preparation of a unified medical insurance code, the national basic medical insurance medication management and supervision. The national medical insurance agency is entrusted by the State Council's administrative department of medical insurance to undertake the specific organization and implementation of the adjustment of the national "Drug Catalogue".
Provincial medical insurance administrative departments are responsible for the management of basic medical insurance medicines in their administrative regions, formulating policies and measures for the management of basic medical insurance medicines in their regions, and supervising the implementation of the Drug List. Provinces based on the national "Drug Catalog", in accordance with the national provisions of the authority and procedures for adjustment of eligible ethnic medicines, medical institutions preparations, traditional Chinese medicine into the provincial medical insurance payment scope, in accordance with the provisions of the State Council administrative department of medical insurance for the record after implementation.
The medical insurance departments of the integrated regions are responsible for the implementation of the Drug List and related policies, auditing, supervising and managing the medication behavior of designated medical institutions in accordance with the medical insurance agreement, settling and paying the medical insurance fees in a timely manner in accordance with the regulations and undertaking the related work of statistical monitoring and information reporting.
Chapter II: Formulation and Adjustment of the Drug List
Article 7: The drugs included in the National Drug List shall be chemical drugs, biological products, proprietary Chinese medicines, and Chinese herbal medicines concocted according to national standards, which are approved by the State Drug Regulatory Administration and have obtained the certificate of registration of the drugs, and meet the basic conditions of being clinically necessary, safe and effective, and reasonably priced. It supports the inclusion of eligible essential medicines in the Drug Catalog as required.
Article 8 of the following medicines are not included in the "Drug List":
The main tonic drugs;
Drugs containing national precious, endangered wild animals and plants;
Health care drugs;
Preventive vaccines and contraceptive medicines;
Mainly enhance the role of sexual function, treatment of alopecia, weight loss, cosmetic, smoking cessation and alcoholism, etc.;
The main role of medicines to enhance sexual function, treatment of hair loss, weight loss, beauty, cessation of smoking, alcoholism
Drugs that cannot be charged separately because they are included in the diagnostic and treatment programs;
Wine preparations, tea preparations, all kinds of fruit-flavored preparations, oral containers and oral effervescent preparations, etc.;
Other medicines that do not comply with the provisions of the basic medical insurance medication.
Article 9: Medicines in the Drug List shall be directly transferred out of the Drug List after evaluation by experts in one of the following cases:
Medicines whose approval certificates have been withdrawn, revoked, or canceled by the drug regulatory authorities;
Medicines included in the Negative List by the relevant departments;
Medicines that have been evaluated and found to be inappropriate for the basic medical insurance after comprehensively considering the clinical value, adverse reactions, and drug Economy and other factors, assessed that the risk is greater than the benefit of the drugs;
The drugs that entered the Drug List through fraud and other irregularities;
Other circumstances stipulated by the state should be directly transferred out.
Article 10: Medicines in the Medicines Catalog may be transferred out of the Medicines Catalog after expert evaluation and other prescribed procedures if any of the following circumstances are met:
Medicines in the same therapeutic area with obviously high prices or costs and without reasonable justification;
Medicines of inaccurate clinical value, which can be better substituted;
Other medicines that do not meet the conditions of safety, efficacy, economy and so on;
Other circumstances that do not meet the conditions of safety, efficacy, economy and so on.
Other medicines that do not meet the conditions of safety, efficacy, economy, and so on.
Article 11 of the State Council administrative department of medical insurance to establish and improve the dynamic adjustment mechanism, in principle, once a year.
The State Council administrative department of medical insurance according to the demand for medical insurance drug protection, basic medical insurance fund income and expenditure, affordability, directory management priorities and other factors, to determine the scope of the adjustment of the "Drug Catalog" and the specific conditions, study and formulate the adjustment of the work program, in accordance with the law, to seek the views of the relevant departments and relevant parties and to the public. The drugs declared by enterprises and meeting the conditions for the adjustment of the Drug Catalog for that year are included in the scope of the adjustment for that year.
Article XII establishes a mechanism for convergence between access to the Medicines Catalog and payment standards for medicines under the health insurance scheme. In addition to traditional Chinese medicine tablets, in principle, newly included in the "Drug List" of drugs synchronized to determine the payment standard.
Exclusive medicines will have their payment standards determined through access negotiations.
In the case of non-exclusive drugs, the drugs selected in the centralized procurement of drugs organized by the State shall determine the payment standard in accordance with the relevant provisions on centralized procurement; and the payment standard for other non-exclusive drugs shall be determined in accordance with the access bidding and other methods.
Narcotic drugs and psychotropic drugs of the first category that are priced by the government, the payment standard is determined in accordance with the government's pricing.
Article 13 of the Chinese traditional medicine tablets are adjusted by means of expert evaluation, and the adjustment procedures for other medicines mainly include enterprise declaration, expert evaluation, negotiation or access bidding, and announcement of the results.
Article 14 establishes the enterprise declaration system. According to the scope of adjustment in the current year, eligible enterprises submit the necessary information to the state medical insurance agency in accordance with the regulations. The specific requirements and methods for submitting the information are formulated separately.
Article 15 of the State Medical Insurance Agency in accordance with the provisions of the organization of medicine, pharmacy, pharmacoeconomics, health insurance management and other experts, to meet the conditions of the current year's adjustment of the "Drug List" of all the drugs for evaluation, and put forward the following list of drugs:
Recommended for inclusion in the new drugs in the "Drug List". After the expert evaluation, the eligible drugs selected in the centralized procurement of state organizations or government-priced drugs can be directly included in the Drug List; other drugs will be submitted in accordance with the provisions of the pharmacoeconomics and other information.
The medicines within the original "Drug Catalog" are recommended to be transferred out directly. This type of drugs are directly transferred from the "Drug Catalog".
The original "Drug List" within the proposal can be transferred out of the drug. The drugs in this category are submitted with information on pharmacoeconomics, etc., as required.
The drugs in the original "Drug List" are recommended to adjust the scope of limited payment. One of the limited scope of payment or expand the limited scope of payment but less impact on the basic medical insurance fund can be adjusted directly; expand the limited scope of payment and a greater impact on the basic medical insurance fund, in accordance with the provisions of the submission of information such as pharmacoeconomics.
Article 16 of the National Health Insurance Agency in accordance with the provisions of the organization of pharmacoeconomics, health insurance management and other aspects of the experts to carry out negotiations or access to bidding. Exclusive drugs into the negotiation process, non-exclusive drugs into the enterprise access bidding process. Negotiation or access bidding success, into the "Drug Catalog" or adjust the limited scope of payment; negotiation or access bidding unsuccessful, not included in or out of the "Drug Catalog", or not adjust the limited scope of payment.
Article XVII of the State Council administrative department of medical insurance is responsible for determining and issuing the "Drug Catalog", announced the results of the adjustment.
Article 18 In principle, the negotiated drug agreement is valid for two years. During the agreement period, if the same generic name of the negotiated drug is listed, the medical insurance department may adjust the payment standard of the drug according to the price level of the generic drug, or the generic name may be included in the scope of centralized purchasing. After the expiration of the agreement period, if the negotiated drugs are still exclusive, the prices and other market environments in neighboring countries and regions have not undergone significant changes and the limited scope of payment has not been adjusted, or if the limited scope of payment has been adjusted but has a relatively small impact on the basic medical insurance fund, the payment standard will be adjusted according to the relevant rules based on the comparison of the actual expenditures of the basic medical insurance fund during the agreement period and the analysis of the impact on the budgets submitted by the enterprises prior to the negotiation, and the agreement will be renewed. agreement. The specific rules are formulated separately.
Article 19 For the need to identify the belonging of the catalog of medicines due to name change, heteronymity and other reasons, the State Council's administrative department of medical insurance shall make the identification in accordance with the procedures and then release it.
Article 20 of the State Council administrative department of medical insurance is responsible for the preparation of the national health insurance drug code, in accordance with the classification of health insurance drugs and code rules to establish a drug code database. In principle, it is updated quarterly.
Chapter III: Use of the Drug Catalog
Article 21: Negotiated drugs during the agreement period are, in principle, purchased directly from the network in accordance with payment standards. During the agreement period, the same generic name of the negotiated drugs in the price is not higher than the negotiation of the payment standard, in accordance with the provisions of the network procurement. Other drugs in accordance with the relevant policies of drug procurement.
Article 22 of the premise of meeting clinical needs, health insurance designated medical institutions shall give priority to the provision and use of the "Drug List" drugs. Gradually establish the "Drug Catalog" and the designated medical institutions drugs equipped with a linkage mechanism, the designated medical institutions in accordance with the "Drug Catalog" adjustment results in a timely manner on the medical institutions to adjust and optimize the drug catalog.
Chapter IV: Payment of Medicare Drugs
Article 23: Expenses incurred by insured persons for the use of medicines in the Drug List shall be paid by the basic medical insurance fund under the following conditions:
For the purpose of diagnosis or treatment of diseases;
Diagnosis and treatment of illnesses are in line with legal indications for medicines and the limited scope of payment by the medical insurance fund;
All expenses incurred by the medical insurance fund shall be paid by the designated medical institutions in accordance with the prescribed conditions.
Provided by the designated medical institutions in accordance with the regulations, except for first aid and resuscitation;
Pharmaceuticals paid for by the integrated fund should be on the basis of a doctor's prescription or hospitalization orders;
Reviewed by a pharmacist or licensed pharmacist in accordance with the prescribed procedures.
Article 24 of the national "Drug List" of Western medicines and proprietary Chinese medicines are divided into "Class A drugs" and "Class B drugs". "Class A medicines" are medicines that are necessary for clinical treatment, widely used, effective, and less expensive or costly in the same category. "Category B drugs" are drugs that can be used as an option for clinical treatment, have proven therapeutic efficacy, and are slightly more expensive or costly than Category A drugs in the same category. The drugs negotiated during the agreement period are included in the management of "Class B drugs".
Ethnic medicines and medical institution preparations that are included in the Drug List by the provincial medical security departments in accordance with national regulations are included in the management of "Class B drugs".
The "Classification A and B" of Chinese herbal medicines is determined by the provincial medical security administrative departments.
Article 25: The use of "Class A drugs" by insured persons shall be paid in accordance with the payment standards and sharing methods stipulated by the basic medical insurance; the use of "Class B drugs" shall be paid in accordance with the payment standards stipulated by the basic medical insurance, and a certain percentage of the payment shall be paid by the insured persons out of their own pockets, and then a certain percentage of the payment shall be paid by the insured persons in accordance with the sharing methods stipulated by the basic medical insurance. The use of "Class B drugs" is subject to the payment standards set by the basic medical insurance, with a certain percentage to be paid by the insured first, and then paid according to the sharing method set by the basic medical insurance.
The proportion of out-of-pocket payment for "Class B drugs" is determined by the provincial or regional medical insurance administrative departments.
Article 26: The payment standard is the basis for the basic medical insurance fund to pay for the cost of medicines when the basic medical insurance participant uses the medicines in the Medicines Catalog. The basic medical insurance fund pays the drug costs to designated medical institutions and designated retail pharmacies based on the payment standards of the drugs as well as the medical insurance payment regulations. The rules for setting and adjusting the payment standards are formulated separately.
Chapter V Management and Supervision of Medicare Drugs
Article 27 makes comprehensive use of agreements, administrative and judicial means to strengthen the supervision of the Drug List and the implementation of the drug policy, and to enhance the safety, effectiveness, and economy of medicines used in medical insurance.
Article 28 of the designated medical institutions should improve the organization, improve the internal system of norms, establish and improve the drug "in, sale, inventory" the whole process of records and management system, improve the medical insurance drug management capacity, to ensure that the medical insurance drug safety and reasonable.
Article 29 incorporates the responsibility for implementation of the Drug List and related policies into the agreements of designated medical institutions, strengthens the reasonableness of the use of medicines and cost audits, and conducts regular supervision and inspection. Medical insurance drug preparation rate, non-medical insurance drug utilization rate and other fixed-point medical institutions linked to the fund payment. Strengthening the supervision and inspection of designated medical institutions in implementing the policies on the management of medicines under medical insurance and fulfilling their responsibilities in the areas of drug preparation, use, payment and management.
Article 30 establishes a monitoring mechanism for pharmaceutical enterprises in the catalog, and guides enterprises to comply with relevant regulations. The enterprise in the promotion and use of drugs, agreement compliance, information reporting and other aspects of behavior and the management of the "Drug Catalog" linked.
Article 31 of the basic medical insurance medication management actively accepts the supervision of the discipline inspection and supervision departments and the community. Strengthen the management of experts, improve the mechanism for the generation of experts, avoidance of interests and accountability. Strengthen the construction of internal control system, improve the complaint and report handling, interest avoidance, confidentiality and other internal management system, the implementation of legality and fair competition review system.
Article 32 For the transfer of medicines into or out of the Medicines Catalog, experts shall submit evaluation conclusions and reports. Gradually establish a mechanism for publicizing evaluation reports and accepting social supervision.
Chapter VI Supplementary Provisions
Article 33 of the general regulations is the format of the "Drug List", the name of the dosage form specification, remarks and other content of the explanation and description.
Western medicine part, the collection of chemical drugs and biological products.
Chinese patent medicines section, containing Chinese patent medicines and ethnic medicines.
The section of negotiated medicines within the agreement period contains medicines within the validity period of the negotiation agreement.
The section on Chinese medicinal tablets contains tablets paid for by the basic medical insurance fund and stipulates that the tablets shall not be included in the payment of the basic medical insurance fund.
Article 34 The medical insurance departments of each province shall, with reference to these provisional measures, formulate specific measures for adjusting the Medicines Catalog in the province within the authority of the State.
Article 35 In the event of a public **** health incident or emergency that seriously endangers the health of the masses, the State Council's administrative department of medical security may temporarily adjust or authorize the provincial administrative department of medical security to temporarily adjust the scope of payment for medicines under medical insurance.
Article 36 In principle, the "Drug Catalog" no longer add OTC drugs.
Article 37 of these measures shall be interpreted by the State Council administrative department of medical insurance, and shall come into force from September 1, 2020 onwards.